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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device acute coronary syndrome event detector
Definition Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
Product CodeQBI
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
2 3 2 1 3 0

MDR Year MDR Reports MDR Events
2023 9 9
2024 12 12
2025 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 12 12
No Clinical Signs, Symptoms or Conditions 11 11
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Angel Medical Systems, Inc. II Feb-11-2025
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